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EC number: 288-327-7 | CAS number: 85711-66-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Resin acids and Rosin acids, esters with glycerol and diethylene glycol
- EC Number:
- 288-327-7
- EC Name:
- Resin acids and Rosin acids, esters with glycerol and diethylene glycol
- Cas Number:
- 85711-66-6
- Molecular formula:
- UVCB substance
- IUPAC Name:
- esterification product of (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-ylidene)-1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,5,6,9,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthrene-1-carboxylic acid and 2,2'-oxydiethanol and propane-1,2,3-triol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M, Lot K02007
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, store protected from light, Test article is not oxygen-sensitive.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: no data.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: no data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no data.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no data.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test article was formulated to 25% (w/v) with distilled water and mixed via vortex.
- Preliminary purification step (if any): no data.
- Final concentration of a dissolved solid, stock liquid or gel: 25% (w/v)
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): no data.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant:yes
- Rationale for use of males (if applicable) : n/a
- Age at study initiation: Animals will be 8 to 12 weeks at the commencement of each dosing.
- Weight at study initiation: The initial weight of each animal will not exceed 20% of the mean of the previously dosed animals of the same sex.
- Fasting period before study: Fresh, Certified Rodent Lab Diet® No. 5002 (or similar) will be available ad libitum during acclimation and the study except for 16 to 20 hours prior to test article administration
- Housing: Animals will be group-housed by dose group in suspended wire-bottom cages that conform to the size recommendations in the Guide for the Care and Use of Laboratory
Animals (National Research Council).
- Historical data: Historical control data is stored by the contract laboratory for statistical comparisons.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5, 50, 300, 2000 or 5000 mg/kg body weight.
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle:no data
- Lot/batch no. (if required): no data
- Purity: no data.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:Initially, a single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg
to three female rats. Since two out of three rats died, an additional six female rats were dosed at a level of 300 mg/kg. - Doses:
- 300 and 2,000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals were dosed at 2,000 mg/kg bw and 6 at 300 mg/kg bw.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals will be observed at least at the following intervals: 15 (± 5) minutes, one, two, and four hours post-dosing, and once daily thereafter for 14 days. All animals will be observed twice daily for mortality on Day 1 through Day 14.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:Observations will include, but not be limited to, evaluation of skin and fur, eyes and
mucous membranes, respiratory and circulatory effects, autonomic effects such as
salivation, central nervous system effects including tremors and convulsions, changes
in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered
strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking
backwards).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level: 2000 mg/kg- two female rats died by dat 4 and one female rat survived following a single 2000 mg/kg oral dose.
Dose Level: 300 mg/kg- all six female rats survived following a single 300 mg/kg oral dose. - Clinical signs:
- other: Chromorhinorrhea, wetness and red staining of the anogenital and nose/mouth area, piloerection, and hunched posture were observed.
- Gross pathology:
- In 2000 mg/kg group- the gross necropsy revealed red staining of the nose/mouth area, red areas on the adrenal glands, and abnormalities of the gastrointestinal tract.
In 300 mg/kg group- the gross necropsy revealed no observable abnormalities. - Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the study, the oral LD50 of the rosin acid derivative was greater than 300 mg/kg but less than 2,000 mg/kg.
- Executive summary:
The acute oral toxicity of Rosin Acid Derivative (Lot:K02007) was tested in Sprague Dawley rats. The study was conducted according to GLP. The test method was conducted based on the OECD Guideline no. 423. The test article was formulated to 25% (w/v) with distilled water and mixed via vortex. The food for each rat was removed from each cage 16-20 hours prior to dosing and each animal was then weighed. The test article was administered orally once on study Day 1 by a syringe and a dosing needle on an mg/kg basis. Animals were observed at least at the following intervals: 15 (± 5) minutes, one, two-, and four-hours post-dosing, and once daily thereafter for 14 days. All animals will be observed twice daily for mortality on Day 1 through Day 14. Surviving animals were euthanized using CO2 and were examined for gross pathology following study termination. Three female rats were initially dosed with 2000 mg/kg test material where two female rats died by Day 4 and one female rat survived the 14-day recovery period. In this group, prior to death, abnormal physical signs of toxicity including chromorhinorrhea, wetness and red staining of the anogenital and nose/mouth area, piloerection, and hunched posture were observed. Terminal body weight loss was observed following the unscheduled deaths. The gross necropsy revealed red staining of the nose/mouth area, red areas on the adrenal glands, and abnormalities of the gastrointestinal tract. The animal that survived the single 2000 mg/kg oral dose gained weight from pretest to study termination and the gross necropsy revealed red areas on the adrenal glands. Subsequently, six female rats were dosed with 300 mg/kg test material. All six female rats survived through the 14-day recovery period. In this group, all six animals gained weight from pretest to study termination. Body weight loss was observed among two animals from Day 7 to Day 14. The gross necropsy revealed no observable abnormalities. Based on the results of the study, the oral LD50 of the rosin acid derivative was greater than 300 mg/kg but less than 2,000 mg/kg.
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